FDA Clears Prescription-Only App for Treating Opioid Use Disorder

The FDA has granted clearance to a mobile medical application designed to help increase patient retention for adults with opioid use disorder (OUD) who are in outpatient treatment programs.^1,2

Pear Therapeutics’ reSET-O app is a prescription-only¹ cognitive behavioral therapy (CBT) and can be downloaded directly to a patient’s mobile device.^1,2

The new app is intended to be used in addition to outpatient treatment under the care of a health care professional and in conjunction with treatment that includes a behavior modification intervention that establishes a connection between new, targeted behavior; buprenorphine and contingency management; and the opportunity to obtain a desired reward, according to the FDA.²

“Digital technologies and data science have incredible potential to unlock the next chapter of medical innovation and to help individuals finally take control of their own health in a meaningful way,” Richard Francis, chief executive officer (CEO) of Sandoz, a division of Novartis and Pear Therapeutics, said in a statement.¹

“New digital therapeutics such as reSET-O also have the potential to fundamentally change how patients interact with their therapies and thus improve patient outcomes," he said. "At Sandoz, we are proud to be a joint pioneer in this exciting new field.”

reSET-O is a 12-week interval prescription digital therapeutic for OUD. The app is modeled on the Community Reinforcement Approach (CRA) and engineered to deliver CBT for patients with OUD. reSET-O delivers CRA therapy as a series of interactive therapy lessons. Each therapy lesson comprises a CBT component and skill-building exercises. Therapy lesson content is delivered primarily via audio or text and may include animations, graphics, and video.¹

According to the FDA, the reSET-O app can serve as a monitoring, reminder, and training tool for health care providers and patients in maintaining an outpatient treatment program. It includes a compliance reward system, such as earning special icons on a prize wheel within the app.²

“As part of our efforts to address the misuse and abuse of opioids, we’re especially focused on new tools and therapies that can help more people with opioid use disorder successfully treat their addiction. Medical devices, including digital health devices like mobile medical apps, have the potential to play a unique and important role in contributing to these treatment efforts," FDA Commissioner Scott Gottlieb, MD, said in a statement.²

"That’s why, for example, we launched an innovation challenge earlier this year to promote the development of medical devices that could help treat addiction. Often on the road to recovery, patients find their commitment to staying in treatment may wane," Gottlieb said.

"Providing Americans suffering from opioid use disorder with more options and proper support to address treatment challenges is key to helping them succeed," he said. "We know medication-assisted treatment works, and we support novel ways to keep individuals more engaged in their treatment programs and to provide clinicians with new ways to intervene to help them remain in treatment.”

The FDA reviewed data from a controlled, multi-site, 12-week, unblinded, clinical trial of 170 patients who received supervised buprenorphine treatment paired with a behavior therapy program, either with or without the addition of a desktop-based version of reSET-O, which was accessed at the clinic. Patients received supervised administration of buprenorphine and urine screens 3 times per week and participated in a contingency management system to reward negative urine tests. The use of reSET-O was not shown to decrease illicit drug use any more than patients who received buprenorphine treatment and contingency management alone. However, the data showed a statistically significant increase in retention in a treatment program for 12 weeks for the patients who used the desktop computer version of the reSET-O program compared with those who did not. In the trial, patients who used the desktop computer version of reSET-O had an overall retention rate through the end of 12 weeks of treatment of 82.4% compared with a 68.4% overall retention rate for patients who did not.²

“Nearly 50,000 drug overdose deaths involving opioids, including prescription pain medications and heroin, took place in the U.S. in 2017,” Corey McCann, MD, PhD, CEO and president of Pear Therapeutics said in a statement.¹

“There is an urgent need for new and innovative therapeutics to address this public health epidemic," he said. "This groundbreaking decision by the FDA ushers in a new standard for treating patients with opioid use disorder and it signals a new path for therapeutic software to be used in conjunction with pharmacotherapy to improve efficacy.”

More than 80% of patients with OUD do not receive or seek out care, and just 13% of outpatient facilities in the United States offer medication-assisted treatment (MAT), according to Pear Therapeutics.

reSET-O could have the potential to dramatically affect this gap in treatment by delivering multi-modal therapy in combination with MAT in a way that is designed to be convenient, easy to access, and more effective for clinicians and patients. reSET-O helps to offer enhanced and standardized care for OUD, providing particular benefit in areas where access to care is inconsistent or unavailable.¹

The reSET-O app has not been shown to decrease illicit drug use or improve abstinence in patients with OUD, according to the FDA.

Data from the clinical studies did not indicate any adverse effects associated with use of the program used in the trial. The adverse events evaluated were typical of patients with OUD, including cardiovascular disease; depression; gastrointestinal diseases; hepatitis C; HIV; mania; nutritional diseases; risk of overdose; and suicidal attempts, behavior, and ideation. The app is not intended to be used for patients whose primary language is not English, as a stand-alone therapy, or as a substitute for medication.²

References

• Sandoz INC. and Pear Therapeutics obtain FDA clearance for reSET-O to treat opioid use disorder [news release]. Boston, MA; December 10, 2018; Pear Therapeutics website. peartherapeutics.com/sandoz-inc-and-pear-therapeutics-obtain-fda-clearance-for-reset-o-to-treat-opioid-use-disorder/. Accessed December 10, 2018.
• FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs [news release]. Silver Spring, MD; December 10, 2018. FDA website. .fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628091.htm. Accessed December 10, 2018.